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Early versus deferred antiretroviral therapy initiation and long-term cardiovascular disease outcomes in people with
Nila J Dharan1, Shweta Sharma2, Alejandro Arenas-Pinto3,4
1Therapeutic and Vaccine Research Program, Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia.
Insights
Delayed antiretroviral therapy (ART) initiation did not worsen cardiovascular disease (CVD) outcomes in people with HIV (PHIV). Immediate ART showed a potential benefit in females, warranting further investigation.
Area of Science:
- Cardiology
- Infectious Diseases
- Public Health
Background:
- Cardiovascular disease (CVD) is a significant concern for people with HIV (PHIV).
- The impact of delayed antiretroviral therapy (ART) initiation on CVD outcomes in PHIV remains unclear.
- This study addresses the critical question of whether deferring ART affects CVD event rates.
Purpose of the Study:
- To compare cardiovascular disease (CVD) event rates between individuals with HIV (PHIV) randomized to immediate versus deferred antiretroviral therapy (ART) initiation.
- To investigate the association between ART timing and CVD outcomes in a large cohort of ART-naïve PHIV.
- To explore potential sex-based differences in the relationship between ART initiation and CVD risk.
Main Methods:
- Randomized controlled trial involving ART-naïve adult PHIV with CD4+ counts > 500 cells/µL.
- Comparison of CVD event rates (myocardial infarction, coronary artery disease requiring revascularization, stroke, CVD-related death) between immediate and deferred ART arms.
- Analysis across different time periods (pre-2016, post-1Jan2016, entire follow-up) and subgroup analyses by baseline characteristics.
Main Results:
- No significant difference in overall CVD event rates was observed between immediate and deferred ART initiation groups (0.17 vs 0.17 per 100 person-years).
- Findings remained consistent across pre-2016 and post-1Jan2016 periods, as well as the entire study follow-up (median 9.3 years).
- A potential benefit of immediate ART was suggested in female participants (HR=0.19), but not in males (HR=1.33), with a significant interaction (P=.014), though event numbers were low.
Conclusions:
- Initiating antiretroviral therapy (ART) immediately versus deferring it was not associated with a reduction in cardiovascular disease (CVD) events in people with HIV (PHIV).
- The observed potential benefit of immediate ART in female participants requires further investigation due to low event counts.
- These findings contribute to understanding the complex interplay between HIV, ART, and cardiovascular health.
Background:
It is unknown whether delayed antiretroviral therapy (ART) initiation worsens CVD outcomes in people with HIV (PHIV). This study compared CVD event rates between PHIV who were randomized to receive immediate versus deferred ART.
Methods:
ART-naïve adult PHIV with CD4+ counts > 500 cells/µL were randomized to immediate versus deferred ART initiation. Event rates for the main composite CVD outcome (myocardial infarction, coronary artery disease requiring revascularization, stroke and CVD-related death) were estimated for: (i) pre-2016 (treatment arms as designed); (ii) post-1Jan2016 (ART use similar across arms); and (iii) entire study follow-up period. Subgroup analyses were performed according to baseline characteristics.
Results:
Among 4684 participants (median age 36 years, 27% female, 30% Black race), 32% were smokers and 17% had a BMI ≥ 30 kg/m2. Comorbidities included hypertension (19%), dyslipidemia (8%), diabetes (3%); 0.8% had a history of CVD. The median time to ART initiation was 2.5 years (interquartile range [IQR] 1.6-3.5 years) in the deferred arm and 7 days (IQR 2-17 days) in the immediate arm. Over the entire study follow-up period (median follow-up of 9.3 years), 71 participants (35 immediate, 36 deferred) experienced a CVD event with no difference in CVD event rates between the immediate and deferred arms (0.17 vs 0.17 per 100 person-years, respectively); these findings were consistent across the pre-2016 and post-1Jan2016 periods. There were 58 CVD events among males (33 immediate; 25 deferred) and 13 among females (2 immediate; 11 deferred). A possible benefit of immediate ART was seen in females but not males (Hazard Ratio = 0.19 [95% confidence interval: 0.04-0.86] vs 1.33 [0.79-2.24]; interaction P-value = .014), though numbers of events were low.
Conclusions:
Early versus deferred ART initiation was not associated with reduced CVD events. The potential benefit associated with immediate ART in female participants warrants further evaluation.
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